Status:
COMPLETED
Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Renal Cell Carcinoma
Stage IV Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer. Monoclonal antibodies, such as bevacizumab, can block ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the frequency of major response in patients with metastatic renal cell cancer treated with bevacizumab and interleukin-2. SECONDARY OBJECTIVES I. Compare the median ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed renal cell cancer
- Metastatic disease
- More than 75% clear cell histology
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No prior refractory disease, defined as clinical or radiologic progression, during or within 3 months after completion of prior interleukin-2 (IL-2)
- Nominally "good" or "intermediate" risk disease, meeting ≥ 4 out of 5 of the following criteria:
- Hemoglobin \> 10 g/dL (except for patients with hereditary hemoglobinopathy)
- ECOG performance status 0-1 (required)
- Calcium normal (corrected)
- Patients with hypercalcemia due to malignancy allowed provided it has been controlled for \> 1 month
- Primary tumor treated or resected by complete nephrectomy, partial nephrectomy, radiofrequency ablation, or other local ablation
- Lactic dehydrogenase \< 1.5 times upper limit of normal (ULN)
- No history of or current brain or CNS metastasis by CT scan or MRI within the past 30 days
- Performance status - ECOG 0-1
- More than 4 months
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 75,000/mm\^3
- No history of bleeding diathesis
- PTT \< 1.5 times ULN
- INR \< 1.5
- Bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN
- No chronic hepatitis B or C
- Creatinine ≤ 2.0 mg/dL
- No proteinuria\* by dipstick urinalysis
- Urine protein ≤ 1,000 mg by 24-hour urine collection
- No symptomatic congestive heart failure
- No uncontrolled hypertension, defined as systolic blood pressure (BP) \> 160 mm Hg and diastolic BP \> 90 mm Hg
- No cardiac arrhythmia
- No peripheral vascular disease ≥ grade 2
- No clinically significant peripheral artery disease
- None of the following arterial thromboembolic events within the past 6 months:
- Transient ischemic attack
- Cerebrovascular accident
- Unstable angina pectoris
- Myocardial infarction
- Not pregnant
- No nursing during and for 3 months after completion of study treatment
- Negative pregnancy test
- Fertile patients must use effective contraception before, during, and for 3 months after completion of study treatment
- No active infection requiring parenteral antibiotics
- No known HIV positivity
- No history of allergic reaction to antibody drugs or IL-2
- No psychiatric illness or social situation that would preclude study compliance
- No non-healing wound or fracture
- No insulin-dependent diabetes
- No other uncontrolled illness
- No other malignancy requiring active treatment within the past 2 years except nonmelanoma skin cancer
- No prior bevacizumab
- At least 6 months since prior immunotherapy containing IL-2
- At least 2 months since prior investigational antibodies
- More than 4 weeks since prior conventional cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No concurrent corticosteroids except replacement corticosteroids for adrenal insufficiency OR inhaled steroids for chronic obstructive pulmonary disease, asthma, or allergic rhinitis
- More than 3 weeks since prior radiotherapy and recovered
- No prior radiotherapy to the only site of measurable disease unless there has been subsequent disease progression
- More than 4 weeks since prior major surgery
- At least 24 hours since prior minor surgical procedure, placement of vascular access device, or fine needle aspiration
- At least 30 days since prior and no other concurrent investigational agents
- More than 10 days since prior anticoagulants
- Low-dose anticoagulants for maintenance of vascular access device patency allowed
- No concurrent therapeutic warfarin, including warfarin for treatment of deep vein thrombosis or pulmonary embolism
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00126490
Start Date
March 1 2005
End Date
August 1 2013
Last Update
June 30 2015
Active Locations (1)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612